The myth of drug expiration dates: ProPublica

Filed Under: Costs, Health plans, Patients

“The box of prescription drugs had been forgotten in a back closet of a retail pharmacy for so long that some of the pills predated the 1969 moon landing,” Marshall Allen writes at ProPublica. “Most were 30 to 40 years past their expiration dates — possibly toxic, probably worthless. But to Lee Cantrell, who helps run the California Poison Control System, the cache was an opportunity to answer an enduring question about the actual shelf life of drugs: Could these drugs from the bell-bottom era still be potent? Cantrell called Roy Gerona, a University of California, San Francisco, researcher who specializes in analyzing chemicals. … The age of the drugs might have been bizarre, but the question the researchers wanted to answer wasn’t. Pharmacies across the country …  routinely toss out tons of scarce and potentially valuable prescription drugs when they hit their expiration dates. Gerona and Cantrell, a pharmacist and toxicologist, knew that the term ‘expiration date’ was a misnomer. The dates on drug labels are simply the point up to which the Food and Drug Administration and pharmaceutical companies guarantee their effectiveness, typically at two or three years. But the dates don’t necessarily mean they’re ineffective immediately after they ‘expire’ — just that there’s no incentive for drugmakers to study whether they could still be usable. … We’ve documented how hospitals often discard pricey new supplies, how nursing homes trash valuable medications after patients pass away or move out, and how drug companies create expensive combinations of cheap drugs. Experts estimate such squandering eats up about $765 billion a year — as much as a quarter of all the country’s health care spending. …  Gerona ran tests on the decades-old drugs, including some now defunct brands. … Overall, the bottles contained 14 different compounds, including antihistamines, pain relievers and stimulants. All the drugs tested were in their original sealed containers. The findings surprised both researchers: A dozen of the 14 compounds were still as potent as they were when they were manufactured, some at almost 100 percent of their labeled concentrations….It turns out that the FDA, the agency that helps set the dates, has long known the shelf life of some drugs can be extended, sometimes by years. In fact, the federal government has saved a fortune by doing this. Marc Young, a pharmacist who helped run the extension program from 2006 to 2009, says it has had a ‘ridiculous’ return on investment. Each year the federal government saved $600 million to $800 million because it did not have to replace expired medication, he says….An official with the Department of Defense, which maintains about $13.6 billion worth of drugs in its stockpile, says that in 2016 it cost $3.1 million to run the extension program, but it saved the department from replacing $2.1 billion in expired drugs. To put the magnitude of that return on investment into everyday terms: It’s like spending a dollar to save $677.” Marshall Allen,
“The Myth of Drug Expiration Dates,” ProPublica.